Articles

The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury

Furosemide is commonly prescribed in critically ill patients with acute kidney injury (AKI). Existing data from observational studies and small clinical trials have significant limitations and have reported co...

Authors: Sean M Bagshaw, R T Noel Gibney, Finlay A McAlister and Rinaldo Bellomo

Multicenter data acquisition made easy

The process for data collection in multicenter trials may be troublesome and expensive. We report our experience with the spreadsheet function in Googledocs for this purpose.

Authors: Jacob Rosenberg, Nadia Abdelaal Henriksen and Lars Nannestad Jørgensen

Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder

Generalised anxiety disorder (GAD) is a high prevalence, chronic psychiatric disorder which commonly presents early in the lifespan. Internet e-health applications have been found to be successful in reducing ...

Authors: Helen Christensen, Adam J Guastella, Andrew J Mackinnon, Kathleen M Griffiths, Claire Eagleson, Philip J Batterham, Kanupriya Kalia, Justin Kenardy, Kylie Bennett and Ian B Hickie

ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of t...

Authors: Markus K Diener, Thomas Bruckner, Pietro Contin, Christopher Halloran, Matthias Glanemann, Hans Jürgen Schlitt, Joachim Mössner, Meinhard Kieser, Jens Werner, Markus W Büchler and Christoph M Seiler

Maintenance Cognitive Stimulation Therapy (CST) for dementia: A single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia

Psychological treatments for dementia are widely used in the UK and internationally, but only rarely have they been standardised, adequately evaluated or systematically implemented. There is increasing recogni...

Authors: Elisa Aguirre, Aimee Spector, Juanita Hoe, Ian T Russell, Martin Knapp, Robert T Woods and Martin Orrell

Comparative effectiveness research: Challenges for medical journals

Editors from a number of medical journals lay out principles for journals considering publication of Comparative Effectiveness Research (CER). In order to encourage dissemination of this editorial, this articl...

Authors: Harold C Sox, Mark Helfand, Jeremy Grimshaw, Kay Dickersin, David Tovey, J André Knottnerus and Peter Tugwell

Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial

The gap between the level of care recommended by evidence-based clinical practice guidelines and the actual care delivered to patients in practice has been well established. The Canadian Diabetes Association (...

Authors: Baiju R Shah, Onil Bhattacharyya, Catherine Yu, Muhammad Mamdani, Janet A Parsons, Sharon E Straus and Merrick Zwarenstein

A systematic review of clinical trials of pharmacological interventions for acute ischaemic stroke (1955-2008) that were completed, but not published in full

We assessed the prevalence, and potential impact of, trials of pharmacological agents for acute stroke that were completed but not published in full. Failure to publish trial data is to be deprecated as it set...

Authors: Lorna M Gibson, Miriam Brazzelli, Brenda M Thomas and Peter AG Sandercock

The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream whi...

Authors: Mara Ozolins, Hywel C Williams, Sarah J Armstrong and Fiona J Bath-Hextall

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

Patients undergoing major elective or urgent surgery are at high risk of death or significant morbidity. Measures to reduce this morbidity and mortality include pre-operative optimisation and use of higher lev...

Authors: Brian H Cuthbertson, Marion K Campbell, Stephen A Stott, Luke Vale, John Norrie, John Kinsella, Jonathan Cook, Julie Brittenden and Adrian Grant

The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial

Each year, worldwide about 530,000 women die from causes related to pregnancy and childbirth. Of the deaths 99% are in low and middle income countries. Obstetric haemorrhage is the leading cause of maternal mo...

Authors: Haleema Shakur, Diana Elbourne, Metin Gülmezoglu, Zarko Alfirevic, Carine Ronsmans, Elizabeth Allen and Ian Roberts

The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial

Recruitment to clinical trials can be challenging. We identified anonymous potential participants to an existing pragmatic randomised controlled depression trial to assess the feasibility of using routinely co...

Authors: Joanna McGregor, Caroline Brooks, Padmaja Chalasani, Jude Chukwuma, Hayley Hutchings, Ronan A Lyons and Keith Lloyd

Does a colour-coded blood pressure diary improve blood pressure control for patients in general practice: The CoCo trial

Insufficient blood pressure control is a frequent problem despite the existence of effective treatment. Insufficient adherence to self-monitoring as well as to therapy is a common reason. Blood pressure self-m...

Authors: Claudia Steurer-Stey, Marco Zoller, Corinne Chmiel Moshinsky, Oliver Senn and Thomas Rosemann

Reporting bias in medical research - a narrative review

Reporting bias represents a major problem in the assessment of health care interventions. Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressan...

Authors: Natalie McGauran, Beate Wieseler, Julia Kreis, Yvonne-Beatrice Schüler, Heike Kölsch and Thomas Kaiser

Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial

Back pain, one of the most prevalent conditions afflicting American adults, is the leading reason for using complementary and alternative medicine (CAM) therapies. Yoga is an increasingly popular "mind-body" C...

Authors: Karen J Sherman, Daniel C Cherkin, Andrea J Cook, Rene J Hawkes, Richard A Deyo, Robert Wellman and Partap S Khalsa

Rationale and design: telephone-delivered behavioral skills interventions for African Americans with type 2 diabetes

African Americans with Type 2 diabetes (T2DM) have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Am...

Authors: Leonard E Egede, Joni L Strom, Valerie L Durkalski, Patrick D Mauldin and William P Moran

Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial - study protocol

Tinnitus is the perception of hearing a sound for which there is no external acoustic source. It is often associated with sudden, temporary hearing loss and has a clear impact on a patient's quality of life. D...

Authors: Nam-Kwen Kim, Dong-Hyo Lee, Jung-Hun Lee, Yong-Leol Oh, In-Hwan Yoon, Eun-Sung Seo and Chung-Ho Lee

Cars, CONSORT 2010, and Clinical Practice

Just like you would not buy a car without key information such as service history, you would not "buy" a clinical trial report without key information such as concealment of allocation. Implementation of the u...

Authors: Hywel C Williams

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline ...

Authors: Kenneth F Schulz, Douglas G Altman and David Moher

Reasons for participating in randomised controlled trials: conditional altruism and considerations for self

Randomised controlled trials of healthcare interventions depend on the participation of volunteers who might not derive any personal health benefit from their participation. The idea that altruistic-type motiv...

Authors: Sharon K McCann, Marion K Campbell and Vikki A Entwistle

A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial

Psychotic disorders are a serious mental health problem. Intervention before the onset of psychosis might result in delaying the onset, reducing the impact or even preventing the first episode of psychosis. Th...

Authors: Judith Rietdijk, Sara Dragt, Rianne Klaassen, Helga Ising, Dorien Nieman, Lex Wunderink, Philippe Delespaul, Pim Cuijpers, Don Linszen and Mark van der Gaag

Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains o...

Authors: Patrick Jahn, Maria Kitzmantel, Petra Renz, Ene Kukk, Oliver Kuss, Anette Thoke-Colberg, Ingrid Horn and Margarete Landenberger

Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials

Recent cohort studies of randomised controlled trials have provided evidence of within-study selective reporting bias; where statistically significant outcomes are more likely to be more completely reported co...

Authors: Joanne E McKenzie, G Peter Herbison, Paul Roth and Charlotte Paul

JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of d...

Authors: Hongbo Cao, Ming Ren, Liping Guo, Hongcai Shang, Junhua Zhang, Yuzhen Song, Hui Wang, Baohe Wang, Xiantao Li, Jing Hu, Xuemei Wang, Dehui Wang, Jianzong Chen, Shuanglei Li and Liming Chen

Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

The incidence of venous ulceration is rising with the increasing age of the general population. Venous ulceration represents the most prevalent form of difficult to heal wounds and these problematic wounds req...

Authors: Carolina D Weller, Sue Evans, Christopher M Reid, Rory Wolfe and John McNeil

The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial

Suicide, attempted suicide and suicidal thoughts are major public health problems worldwide. Effective face-to-face treatments are Cognitive Behavioural Therapy (CBT), Dialectical Behavioural Therapy (DBT) and...

Authors: Bregje A J van Spijker, Annemieke van Straten and Ad J F M Kerkhof

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach

Low back pain (LBP) is a prevalent and costly condition in the United States. Evidence suggests there is no one treatment which is best for all patients, but instead several viable treatment options. Additiona...

Authors: Kristine K Westrom, Michele J Maiers, Roni L Evans and Gert Bronfort

Erratum to: Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Authors: Anthony J Avery, Sarah Rodgers, Judith A Cantrill, Sarah Armstrong, Rachel Elliott, Rachel Howard, Denise Kendrick, Caroline J Morris, Scott A Murray, Robin J Prescott, Kathrin Cresswell and Aziz Sheikh

Studying a disease with no home - lessons in trial recruitment from the PATCH II study

Cellulitis is a very common condition that often recurs. The PATCH II study was designed to explore the possibility of preventing future episodes of cellulitis, with resultant cost savings for the NHS. This wa...

Authors: Kim S Thomas

Rationale and design of the randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder - the EMC trial

In Major Depressive Disorder (MDD), the traditional belief of a delayed onset of antidepressants' effects has lead to the concept of current guidelines that treatment durations should be between 3-8 weeks befo...

Authors: André Tadić, Stanislav Gorbulev, Norbert Dahmen, Christoph Hiemke, Dieter F Braus, Joachim Röschke, Dietrich van Calker, Daniel Wachtlin, Kai Kronfeld, Thorsten Gorbauch, Monika Seibert-Grafe and Klaus Lieb

Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic review

The purpose of the study was to evaluate systematic reviews of research into two public health priorities, tobacco consumption and HIV infection, in terms of the reporting of data related to the applicability ...

Authors: Nizar Ahmad, Isabelle Boutron, Agnès Dechartres, Pierre Durieux and Philippe Ravaud

Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light - a randomized clinical trial

Depression frequently occurs in the elderly and in patients suffering from dementia. Its cause is largely unknown, but several studies point to a possible contribution of circadian rhythm disturbances. Post-mo...

Authors: Els IS Most, Philip Scheltens and Eus JW Van Someren

The effectiveness of joint crisis plans for people with borderline personality disorder: protocol for an exploratory randomised controlled trial

Borderline Personality Disorder (BPD) is a common mental disorder associated with raised mortality, morbidity and substantial economic costs. Although complex psychological interventions have been shown to be ...

Authors: Paul Moran, Rohan Borschmann, Clare Flach, Barbara Barrett, Sarah Byford, Joanna Hogg, Morven Leese, Kim Sutherby, Claire Henderson, Diana Rose, Mike Slade, George Szmukler and Graham Thornicroft

A systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials

Enrolment of patients into a randomised controlled trial (RCT) in violation of key inclusion or exclusion criteria, may lead to excess avoidable harm. The purpose of this paper was to systematically identify a...

Authors: Fiona Simpson, Elizabeth A Sweetman and Gordon S Doig

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus (T2DM). Latent phase identification through screening requires structured, approp...

Authors: DR Webb, K Khunti, B Srinivasan, LJ Gray, N Taub, S Campbell, J Barnett, J Henson, S Hiles, A Farooqi, SJ Griffin, NJ Wareham and MJ Davies

The randomized shortened dental arch study (RaSDA): design and protocol

Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of t...

Authors: Ralph G Luthardt, Birgit Marré, Achim Heinecke, Joachim Gerss, Hans Aggstaller, Eckhard Busche, Paul Dressler, Ingrid Gitt, Wolfgang Hannak, Sinsa Hartmann, Guido Heydecke, Florentine Jahn, Matthias Kern, Torsten Mundt, Peter Pospiech, Helmut Stark…

Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial

Previous research has shown the oxidizing properties and microbiological efficacies of chlorine dioxide (ClO₂). Its clinical efficacies on oral malodor have been evaluated and reported only in short duration tria...

Authors: Kayoko Shinada, Masayuki Ueno, Chisato Konishi, Sachiko Takehara, Sayaka Yokoyama, Takashi Zaitsu, Mari Ohnuki, Fredrick Allan Clive Wright and Yoko Kawaguchi

Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED)

The National Dementia Strategy seeks to enhance general practitioners' diagnostic and management skills in dementia. Early diagnosis in dementia within primary care is important as this allows those with demen...

Authors: Steve Iliffe, Jane Wilcock, Mark Griffin, Priya Jain, Ingela Thuné-Boyle, Tamar Koch and Frances Lefford

The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae

Verrucae are a common, infectious and sometimes painful problem. The optimal treatment for verrucae is unclear due to a lack of high quality randomised controlled trials. The primary objective of this study is...

Authors: E Sarah Cockayne

Feasibility study to inform the design of a randomised controlled trial to eradicate Pseudomonas aeruginosa infection in individuals with Cystic Fibrosis

There are controversies about the most effective treatment to eradicate first growth of Pseudomonas aeruginosa (P aeruginosa) from the lower airways of patients with cystic fibrosis (CF). UK guidelines recommend ...

Authors: Helen R Hickey, Ashley P Jones, Warren Lenney, Paula R Williamson and Rosalind L Smyth

The STRIPES Trial - Support to Rural India's Public Education System

Performance of primary school students in India lags far below government expectations, and major disparity exists between rural and urban areas. The Naandi Foundation has designed and implemented a programme ...

Authors: Alex Eble, Vera Mann, Preetha Bhakta, Rashmi Lakshminarayana, Chris Frost, Diana Elbourne and Peter Boone

Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers

In recognition of the benefits of transparent reporting, many peer-reviewed journals require that their authors be prepared to share their raw, unprocessed data with other scientists and/or state the availabil...

Authors: Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers and Douglas G Altman

The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

Depression is a leading cause of disability worldwide and depressive symptoms are common in later life. Observational evidence suggests that depression is more prevalent among people with high plasma homocyste...

Authors: Andrew H Ford, Leon Flicker, Kieran McCaul, Frank van Bockxmeer, Sarah Hegarty, Varsha Hirani, Stephen Fenner and Osvaldo P Almeida

Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the...

Authors: Joanne E McKenzie, Patricia Priest, Rick Audas, Marion R Poore, Cheryl R Brunton and Lesley M Reeves

Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

Regular physical activity reduces the risk of mortality from all causes, with a powerful beneficial effect on risk of falls and hip fractures. However, physical activity levels are low in the older population ...

Authors: Steve Iliffe, Denise Kendrick, Richard Morris, Dawn Skelton, Heather Gage, Susie Dinan, Zoe Stevens, Mirilee Pearl and Tahir Masud

Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme E uropean QU ality I mprovement P rogramme for A cute C oronary S yndrome: The EQUIP-ACS project protocol and design

Acute coronary syndromes, including myocardial infarction and unstable angina, are important causes of premature mortality, morbidity and hospital admissions. Acute coronary syndromes consume large amounts of ...

Authors: Marcus D Flather, Jean Booth, Daphne Babalis, Hector Bueno, Philippe G Steg, Grzegorz Opolski, Filippo Ottani, Jacques Machecourt, Alfredo Bardaji, Mats Bojestig, Anthony R Brady and Bertil Lindahl

Alberta Diabetes and Physical Activity Trial (ADAPT): A randomized theory-based efficacy trial for adults with type 2 diabetes - rationale, design, recruitment, evaluation, and dissemination

The primary aim of this study was to compare the efficacy of three physical activity (PA) behavioural intervention strategies in a sample of adults with type 2 diabetes.

Authors: Ronald C Plotnikoff, Kerry S Courneya, Ronald J Sigal, Jeffrey A Johnson, Nicholas Birkett, David Lau, Kim Raine, Steven T Johnson and Nandini Karunamuni

Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial

Marfan syndrome (MFS) is one of the most common systemic disorders of connective tissue with the incidence of approximately 2-3 per 10 000 individuals. Aortic disease, leading to progressive aneurysmal dilatat...

Authors: Teodora Radonic, Piet de Witte, Marieke JH Baars, Aeilko H Zwinderman, Barbara JM Mulder and Maarten Groenink

Questionnaires in clinical trials: guidelines for optimal design and administration

A good questionnaire design for a clinical trial will minimise bias and maximise precision in the estimates of treatment effect within budget. Attempts to collect more data than will be analysed may risk reduc...

Authors: Phil Edwards

A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

Paclitaxel-eluting stents decrease angiographic and clinical restenosis following percutaneous coronary intervention compared to bare metal stents. TAXUS Element is a third-generation paclitaxel-eluting stent ...

Authors: Dominic J Allocco, Louis A Cannon, Amy Britt, John E Heil, Andrey Nersesov, Scott Wehrenberg, Keith D Dawkins and Dean J Kereiakes